Royal Jelly as a Strategy to Modulate Inflammation and Oxidative Stress in Patients With Systemic Arterial Hypertension

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversidade Federal Fluminense

About this trial

The study aims to evaluate the effect of the royal jelly on inflammation and oxidative stress in participants with systemic arterial hypertension. A longitudinal double-blind randomized clinical trial will be carried out, involving hypertensive participants for two months.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of stage 1 hypertension

Regular treatment for more than 6 months

No changes in medication doses during the last 3 months

Disqualifiers

Autoimmune diseases

Infectious diseases

Diabetes

Chronic kidney disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Royal Jelly

    Dietary supplement

    Participants will receive 2 capsules per day, providing the dosage of 300mg of royal jelly for 2 months (8 weeks).

  • Placebo

    Dietary supplement

    The placebo group will receive 2 capsules per day (containing microcrystalline cellulose and magnesium stearate in colored gelatin capsules capable of masking the appearance of the internal content), at the same time for 2 months.

Treatment groups

34 Participants
are divided into 2 treatment groups
Group A: Royal Jelly GroupExperimental treatment 1 intervention
Group B: Placebo GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of inflammatory transcripton factor

Assessment of NFkB expression levels in blood samples collected at baseline and after 8 weeks of supplementation.

Time frame
Baseline and 8 weeks

Secondary outcomes

1

Change in interleukin-6 (IL-6) levels

Assessment of changes in serum interleukin-6 (IL-6) levels after supplementation.

Time frame
Baseline and 8 weeks
2

Change in tumor necrosis factor-alpha (TNF-α) levels

Assessment of changes in serum tumor necrosis factor-alpha (TNF-α) levels after supplementation.

Time frame
Baseline and 8 weeks
3

Change in Nrf2 expression

Assessment of changes in Nrf2 expression after supplementation.

Time frame
Baseline and 8 weeks
4

Change in C-reactive protein (CRP) levels

Assessment of changes in serum C-reactive protein (CRP) levels after supplementation.

Time frame
Baseline and 8 weeks

Other outcomes

Sponsors and contacts

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